Norme ISO 13485:2003

The main objective of ISO 13485:2003 is to facilitate the implementation of harmonized regulatory requirements for medical devices as part of the management systems of quality.

So thanks to ISO 13485, Microvitae meets system requirements for quality management by demonstrating daily his ability to consistently provide medical devices (manufacture and marketing of evoked potentials) in accordance with customer requirements and international standards.

ISO 13485 is an international standard that specifies requirements for medical device manufacturers. The main goal of ISO 13485 is to provide a harmonized model for quality management system requirements in the international market. ISO 13485 compliance is therefore of critical importance. (Note that ISO 13485 2003 has replaced ISO 13485 1996.)